Search FDA Product-Specific Guidances
Search FDA's product-specific guidances (PSGs) for generic drug development: FDA's recommendations for one active ingredient and dosage form (the bioequivalence studies, their design, strength and analyte, waivers, dissolution), listed per reference listed drug (RLD). PSGs are not in search_guidance. Find by active ingredient, RLD application number, draft or final, or words in the text. Each result gives the ingredient, route, dosage form, RLD numbers, status and the date FDA recommended it. Earlier PSG files FDA no longer lists are left out unless includeUnlisted. Call read_fda_psg for the text.
Request
- Base URLhttps://api.assyro.com
- Authnone declared
Query parameters
The active ingredient, e.g. "apixaban" or "levothyroxine sodium".
A reference listed drug's NDA number, e.g. "202155".
Words in the PSG, e.g. "fed bioequivalence" or "in vitro permeation test".
Only draft or only final PSGs.
Also return earlier PSG files the database no longer lists (mostly superseded versions); default false.
PSGs to return, default 8.
Skip this many results (for paging), default 0.
Response
Matching records.
Changes
No recorded changes to this operation across all 1 revision of this API.